Quality is a main priority for MEDICORE.
Our Quality Management System is fundamental to our operations and a key principle of MEDICORE.
It ensures compliance of our commitments, regulatory requirements and customers’ expectations, and it continuously improves our operations, leading to even higher customer satisfaction.
Every MEDICORE employee is familiar with our Corporate Quality Policy and behaves accordingly. Our Corporate Quality Policy stipulates the following governing principles:
Our Quality Management System includes:
Our Quality Management system ensures that the highest standards and policies are built into our operations and implemented at our facilities.
Conducting clinical studies in Ukraine is strictly regulated by a number of authorities.
It involves planning projects beyond standard clinical studies regulations and considering the local regulatory requirements to pharmaceuticals, medical devices and other related supplies handling.
While regulation in Ukraine is mainly in line with international industry and GxP standards, there are some local differences that need to be considered.
The majority of important differences are related to extremely strict requirements on documenting any product/supply transfer, for example, from exporter to importer and from local depot to investigational sites.
That is why the critically important tasks of adequate accounting, tracking and arrangement of shipment should be performed by an experienced logistics provider.
MEDICORE is such an experienced provider. We have been successfully providing clinical logistics services (in line with local pharmaceutical, accounting, taxation regulation and international/sponsors’ requirements) since 2007.
Our regulatory specialists frequently attend advisory sessions and seminars organized by RA in order to remain up-to-date in the changing regulatory environment.